MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	DUCT OCCLUDER
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 12-10mm amplatzer duct occluder was selected for procedure.It was noted during procedure that the amplatzer duct occluder exhibited a deformation when being deployed through a 8fr non-abbott delivery sheath.The decision was made to replaced the 12-10mm amplatzer duct occluder with another amplatzer duct occluder of a different unknown size to complete the procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity was reported.The investigation confirmed the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.Per the instructions for use, the recommended size delivery system for use with a 9-pda-007 amplatzer amplatzer duct occluder is a 7f.
Event or Problem Description
It was reported that on 10 august 2022, a 12-10mm amplatzer duct occluder was selected for procedure.It was noted during procedure that the amplatzer duct occluder exhibited a deformation when being deployed through a 8fr non-abbott delivery sheath.The decision was made to replaced the 12-10mm amplatzer duct occluder with another amplatzer duct occluder of a different unknown size to complete the procedure.Subsequent to the previously filed report, additional information was received that: the amplatzer septal occluder exhibited a cobra deformation when being deployed.There was no angulation or kinks noted in the delivery system.The original occluder was never released from the delivery cable and did not interact with any cardiac structures during deployment.The device was replaced with a 10-8mm amplatzer duct occluder (8094671).The patient was reported as stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15375631
• Report Number: 2135147-2022-01050
• Device Sequence Number: 5809501
• Product Code: MAE
• UDI-Device Identifier: 00811806011141
• UDI-Public: 00811806011141
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-007
• Device Lot Number: 6655399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8FR MULLINS SHEATH
• Patient Sex: Unknown